Assistant Manager, Regulatory Affairs

Growth For Impact; Ahmedabad District; On-site; INR 800,000 - 1,200,000; Full time

Job summary

CleanMax is seeking a Regulatory Affairs professional to lead submissions for CTD/ACTD dossiers and oversee modules 1–5 coordination with QA, R&D, and manufacturing teams.

You will ensure compliance with WHO/ICH guidelines, develop RoW strategies, and manage post-approval changes while supporting business development and regulatory oversight.

Responsibilities

• Prepare, review, and submit CTD / ACTD / country-specific dossiers for new product registrations, line extensions, variations, and renewals
• Coordinate compilation of Modules 1–5 with QA, QC, R&D, CMC, Pharmacovigilance, and Manufacturing teams
• Ensure dossier compliance with WHO, ICH, and local authority guidelines
• Develop registration strategies for RoW markets considering country-specific regulations
• Support business development by providing regulatory feasibility and timelines for new markets/products
• Assess regulatory impact for formulation/site changes
• Manage post-approval changes, including CMC variations, labeling updates, and artwork changes
• Track and ensure timely renewals/re-registrations
• Maintain approved product documentation and regulatory databases
• Handle deficiency letters/queries from regulatory agencies
• Prepare responses in coordination with internal stakeholders
• Liaise with local agents, consultants, and partners for RoW countries
• Monitor regulatory guideline updates for RoW markets
• Ensure submissions comply with the latest country requirements
• Support internal audits, regulatory inspections, and due-diligence audits
• Mentor junior team members and review their regulatory work
• Track regulatory milestones and ensure alignment with project timelines
• Participate in cross-functional meetings for project planning and risk assessment

Job description

ROLE

• Prepare, review, and submit CTD / ACTD / country-specific dossiers for new product registrations, line extensions, variations, and renewals
• Coordinate compilation of Modules 1–5 with QA, QC, R&D, CMC, Pharmacovigilance, and Manufacturing teams
• Ensure dossier compliance with WHO, ICH, and local authority guidelines
• Develop registration strategies for RoW markets considering country-specific regulations
• Support business development by providing regulatory feasibility and timelines for new markets/products
• Assess regulatory impact for formulation/site changes
• Manage post-approval changes, including CMC variations, labeling updates, and artwork changes
• Track and ensure timely renewals/re-registrations
• Maintain approved product documentation and regulatory databases
• Handle deficiency letters/queries from regulatory agencies
• Prepare responses in coordination with internal stakeholders
• Liaise with local agents, consultants, and partners for RoW countries
• Monitor regulatory guideline updates for RoW markets
• Ensure submissions comply with the latest country requirements
• Support internal audits, regulatory inspections, and due-diligence audits
• Mentor junior team members and review their regulatory work
• Track regulatory milestones and ensure alignment with project timelines
• Participate in cross-functional meetings for project planning and risk assessment